FDA 483 - Anika Therapeutics, Inc. - September 21, 2017

Anika Therapeutics, Inc. in Bedford, MA, received a Form 483 with six observations during an FDA inspection. The firm was cited for inadequate investigations into product contamination complaints and failing to follow CAPA for requalifying environmental chambers. Additional deficiencies included poor environmental monitoring practices in aseptic areas, facility maintenance issues, lax control over drug product labeling, and unsupported raw material sampling procedures.